The following data is part of a premarket notification filed by 3d Industrial Imaging Co.,ltd. with the FDA for Dentiq3d.
Device ID | K160666 |
510k Number | K160666 |
Device Name: | Dentiq3D |
Classification | System, Image Processing, Radiological |
Applicant | 3D INDUSTRIAL IMAGING CO.,LTD. 413 Institute Of Computer Technology Seoul National University, Daehak-dong, Gwanak-gu, KR |
Contact | Jin Sa Kim |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 110 Irvine, CA 92620 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-09 |
Decision Date | 2016-10-05 |
Summary: | summary |